NIRAVAM
LOE ApproachingNDAORALTABLET, ORALLY DISINTEGRATING
Approved
Jan 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
NIRAVAM by UCB Pharma is clinical pharmacology pharmacodynamics cns agents of the 1,4 benzodiazepine class presumably exert their effects by binding at stereo specific receptors at several sites within the central nervous system. Approved for anxiety disorder (a condition corresponding most closely to the apa diagnostic, statistical manual [dsm-iii-r] diagnosis of generalized anxiety disorder), the short-term relief of symptoms of anxiety and 3 more indications. First approved in 2005.
Drug data last refreshed 22h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NIRAVAM is an orally disintegrating tablet formulation of alprazolam, a 1,4-benzodiazepine CNS depressant that binds to stereospecific receptors to produce anxiolytic and sedative effects. It is indicated for generalized anxiety disorder, short-term anxiety symptom relief, and panic disorder with or without agoraphobia. The drug works by enhancing GABAergic inhibition in the central nervous system, though the exact mechanism remains incompletely understood.
LOE Approaching
As a mature product approaching loss of exclusivity with moderate competitive pressure (30 score), the brand team is likely consolidating operations and focusing on loyalty and managed care contracting rather than expansion.
Mechanism of Action
CLINICAL PHARMACOLOGY Pharmacodynamics CNS agents of the 1,4 benzodiazepine class presumably exert their effects by binding at stereo specific receptors at several sites within the central nervous system. Their exact mechanism of action is unknown. Clinically, all benzodiazepines cause a…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.